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A Prospective, Randomized Comparison of Bivalirudin vs. Heparin Plus Glycoprotein IIb/IIIa Inhibitors During Primary Angioplasty in Acute Myocardial Infarction – 30 Day Results – Gregg W. Stone MD For the HORIZONS AMI Investigators. Disclosures. Gregg W. Stone MD

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  1. A Prospective, Randomized Comparison of Bivalirudin vs. Heparin Plus Glycoprotein IIb/IIIa Inhibitors During Primary Angioplasty in Acute Myocardial Infarction – 30 Day Results – Gregg W. Stone MD For the HORIZONS AMI Investigators

  2. Disclosures Gregg W. Stone MD Research support from The Medicines Company and Boston Scientific Honoraria from Eli Lilly Co.

  3. Background In addition to suppressing periprocedural ischemia, prevention of hemorrhagic complications has emerged as a priority in patients undergoing PCI In patients with stable angina and NSTEMI, the direct thrombin inhibitor bivalirudin has been shown to result in similar rates of composite ischemia as heparin plus GP IIb/IIIa inhibitors, while significantly reducing major bleeding Whether bivalirudin has comparable safety and efficacy in patients with STEMI undergoing primary PCI is unknown

  4. Harmonizing Outcomes with Revascularization and Stents in AMI ≥3400* pts with STEMI with symptom onset ≤12 hours Aspirin, thienopyridine UFH + GP IIb/IIIa inhibitor (abciximab or eptifibatide) Bivalirudin monotherapy (± provisional GP IIb/IIIa) Emergent angiography, followed by triage to… R 1:1 R 1:3 CABG – – Primary PCI Medical Rx 3000 pts eligible for stent randomization TAXUS paclitaxel-eluting stent Bare metal stent Clinical FU at 30 days, 6 months, 1 year, and then yearly through 5 years *To rand 3000 stent pts

  5. Harmonizing Outcomes with Revascularization and Stents in AMI ≥3400* pts with STEMI with symptom onset ≤12 hours Aspirin, thienopyridine UFH + GP IIb/IIIa inhibitor (abciximab or eptifibatide) Bivalirudin monotherapy (± provisional GP IIb/IIIa) Pharmacology Arm Primary Endpoints* 30 Day Intention to Treat Population R 1:1 * All stent randomization results are still blinded

  6. 30 Day Study Objectives • In patients with STEMI undergoing a primary PCI strategy, compared to UFH plus the routine use of GP IIb/IIIa inhibitors, bivalirudin monotherapy will result in: • Similar or reduced rates of net adverse clinical events (the composite of ischemic major adverse cardiovascular events and major bleeding) at 30 days • Similar or reduced rates of major bleeding at 30 days

  7. 2 Primary Endpoints (at 30 Days) 1) Net Adverse Clinical Events and 2) Major Bleeding (non CABG) • Intracranial bleeding • intraocular bleeding • Retroperitoneal bleeding • Access site bleed requiring • intervention/surgery • Hematoma ≥5 cm • Hgb ≥3g/dL with an overt source • Hgb ≥4g/dL w/o overt source • Reoperation for bleeding • Blood product transfusion

  8. 2 Primary Endpoints (at 30 Days) 1) Net Adverse Clinical Events = 2) Major Bleeding (non CABG) or Major adverse cardiovascular events (major secondary endpoint) • All cause death • Reinfarction • Ischemic TVR • Stroke

  9. Harmonizing Outcomes with Revascularization and Stents in AMI 3602 pts with STEMI R 1:1 UFH + GP IIb/IIIa N=1802 Bivalirudin Monotherapy N=1800 Randomized 9 15 • • • Withdrew • • • • • • Lost to FU • • • 10 13 N=1778 (98.7%) N=1777 (98.7%) 30 day FU* ITT population N=1802 N=1800 * Range ±7 days

  10. Primary Management Strategy* UFH + GP IIb/IIIa Inhibitor N=1802 Bivalirudin Monotherapy N=1800 Primary PCI CABG Deferred PCI Medical Rx *Primary ITT analysis includes all pts regardless of treatment

  11. Primary Outcome Measures (ITT) Diff = -2.9% [-4.9,-0.8] RR = 0.76 [0.63,0.92] PNI ≤ 0.0001 Psup = 0.006 Diff = -3.3% [-4.0,-1.6] RR = 0.60 [0.46,0.77] PNI ≤ 0.0001 Psup ≤ 0.0001 Diff = 0.0% [-1.6,1.5] RR = 0.99 [0.76,1.30] Psup = 1.00 1 endpoint 1 endpoint • *Not related to CABG • **MACE = All cause death, reinfarction, ischemic TVR or stroke

  12. 30 Day MACE Components* *CEC adjudicated

  13. Conclusions • In this large scale, prospective, randomized trial of pts with STEMI undergoing a primary PCI management strategy, compared to UFH plus the routine use of GP IIb/IIIa inhibitors, bivalirudin monotherapy with GP IIb/IIIa inhibitors reserved for suboptimal PCI outcomes resulted in: • A significant 24% reduction in the 30 day primary endpoint of net adverse clinical events • A significant 40% reduction in the 30 day primary endpoint of major bleeding

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